Nicorandil 10mg, 20mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Nicorandil Tablets are and what they are used for
2. Before you take Nicorandil Tablets
3. How to take Nicorandil Tablets
4. Possible side effects
5. How to store Nicorandil Tablets
6. Further information

Do not take Nicorandil Tablets and tell your doctor if:

• You are allergic (hypersensitive) to nicorandil or any of the other ingredients of Nicorandil Tablets (see section 6 -"Further information"). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have low blood pressure (signs include feeling dizzy, light-headed or faint)
• You have a heart problem where the heart is damaged and cannot pump enough blood around the body
• You have heart failure (signs include shortness of breath, swollen ankles and legs, and feeling tired)
• You are taking medicines for erectile dysfunction (impotence) such as sildenafil, tadalafil or vardenafil

Do not take this medicine if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nicorandil Tablets.

Take special care with Nicorandil Tablets

Check with your doctor or pharmacist before taking this medicine if:

• You have been told by your doctor that you have low blood volume or low systolic blood pressure
• You have recently had a heart attack
• You have a build up of fluid in the lungs (pulmonary oedema)
• You have mouth ulcers

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Nicorandil Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Nicorandil Tablets can affect the way some other medicines work. Also some medicines can affect the way Nicorandil Tablets work.

In particular, do not take Nicorandil Tablets, and tell your doctor if you are taking:

• Medicines for erectile dysfunction (impotence) such as sildenafil, tadalafil or vardenafil

Tell your doctor if you are taking any of the following:

• Medicines that widen the blood vessels such as hydralazine, minoxidil or nitroprusside (vasodilators)
• Medicines for high blood pressure
• Medicines for depression
• Medicines for inflammation (corticosteroids such as prednisolone)

Taking Nicorandil Tablets with food and drink

Do not drink alcohol while you are taking Nicorandil Tablets.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may be pregnant.

You should not breast-feed if you are taking Nicorandil Tablets. This is because small amounts of this medicine may pass into mothers' milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.

Taking this medicine

• Take this medicine by mouth
• Swallow the tablets whole with a drink of water. Do not crush or chew the tablets
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

• The usual dose is 10mg or 20mg taken twice a day, once in the morning and once in the evening.
• Your doctor might increase this to 30mg twice a day if necessary.
• If you have tendency to get headaches, your doctor may start you on a lower dose of 5mg (half of a 10mg tablet) twice a day.

Use in children

Nicorandil Tablets are not recommended for use in children.

If you take more Nicorandil Tablets than you should

If you take more tablets than you should, tell a doctor or go to a hospital casualty department immediately. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: you may feel dizzy or weak or have difficulty in breathing or wheezing.

If you forget to take Nicorandil Tablets

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for you to take your next dose, skip the dose you missed and continue to follow the dosing schedule as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Nicorandil Tablets

Keep taking Nicorandil Tablets until your doctor tells you to stop. Do not stop taking Nicorandil Tablets because you feel better. If you stop, your illness may get worse or come back.

Stop taking Nicorandil Tablets and see a doctor immediately or go to a hospital straight away if you have the following side effects:

Very rare (affects less than 1 in 10,000 people)

• Red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching, difficulty breathing or swallowing. This could be an allergic reaction (angioedema).
• Yellowing of your skin or eyes (which may be signs of liver problems).

Tell your doctor immediately if you have any of the following side effects:

Common (affects less than 1 in 10 people)

• Increased or fast heart-beat

Rare (affects less than 1 in 1000 people)

• Blood in your stools or vomit, due to ulcers in the stomach or gut
• Ulcers of the back passage, bleeding from the back passage

Very rare (affects less than 1 in 10,000 people)

• Ulcers of the genital tract
• Skin ulcers, possibly on the hands, legs, or feet
• Ulcers in the nasal passages
• Ulcers around a stoma (in those with an artificial opening for waste removal such as a colostomy or ileostomy)

Tell your doctor as soon as possible if you have any of the following:

Very common (affects more than 1 in 10 people)

• Headache. These are more common when you first start taking Nicorandil Tablets.

Common (affects less than 1 in 10 people)

• Feeling dizzy or weak
• Feeling sick or being sick
• Flushing of the skin

Uncommon (affects less than 1 in 100 people)

• Feeling lightheaded or fainting (due to low blood pressure)
• Mouth ulcers
• Pain in your muscles

Rare (affects less than 1 in 1000 people)

• Skin rashes

Very rare (affects less than 1 in 10,000 people)

• Stomach pain

What Nicorandil Tablets contain

• The active substance is nicorandil. Each 10mg tablet contains 10mg nicorandil. Each 20mg tablet contains 20mg nicorandil.
• The other ingredients are: cetyl alcohol, mannitol, croscarmellose sodium, povidone, silica colloidal anhydrous and sodium stearyl fumarate.

What Nicorandil Tablets look like

The tablets are white to off-white, round, scored on one side and engraved with "10" or "20" on the other side. The tablets can be divided into equal halves.

Contents of the pack

Nicorandil Tablets are available in packs of 10, 28, 30, 56 and 60 tablets in blister strips.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: